The field of the electric stimulation of tissues has been recently extended to include devices that electrically stimulate many organs, intra- and extra-abdominal, through electrodes implanted in the tissue.
The electrical connection between the pulse generator and the electrodes implanted in the organ or tissue of the body can be obtained through one or more wires defined as electrocatheters (leads).
Recently some studies have highlighted that electric stimulation of the stomach effectively combats obesity, GE arterial hypertension, type 2 diabetes, depressive disorder and even psoriasis, all diseases marked by orthosympathetic hypertone.
Scientific research is committed to the effort for understanding the operating mechanisms, and the areas, of electric stimulation in the modulation of the Autonomic Nervous System in pathological processes associated with an imbalance thereof.
A prestigious publication (Gene-Jack) describes the detectable modifications in some areas of the brain, mapped using brain imaging, in patients subjected to electric stimulation of the stomach.
This discovery reinforces the concept that the stomach, like other organs or body sites, need not be considered as the receiver of the stimulation, but as a means through which information can be sent to the Central Nervous System (through electrical code pulses applied to the nervous fibres contained in the gastric wall or in other sites), the real final receiver. Just as for the stomach, it is desirable to also have other centres of stimulation that can be used for this purpose, present in other areas of the human body.
The stimulation of these areas is exploited to correct pathological decompensations of the sympathetic/parasympathetic system.
The adjustment of all the electric stimulation devices which act in order to correct these decompensations is based on heart rate variability.
This heart rate variability (HRV) data can also be used for the early diagnosis of possible cardiovascular and/or metabolic events.
All electric stimulators or pacemakers currently in use, both for gastric stimulation and for stimulation of the intra-abdominal organs and other neurological tissues, need one or more connecting electrocatheters, with different shapes and sizes, between the appliance and the organ or the target tissue of the stimulation, a battery as a source of electrical energy for the stimulation, and a surgical operation for the implantation process.
The shape of the stimulator forces the surgeon to have to make a visible cut on the skin of the abdomen or another site of the body, which is necessary in order to create the subcutaneous pocket in which the stimulator will be housed.
Clinical experience has highlighted that the presence of the subcutaneous pocket and that of the electrocatheter can cause technical problems during the course of the therapy.
In particular, the electrocatheter entails various drawbacks due to the possibility of breaking, its displacement, penetration, erosion and/or perforation of the organ at the housing point, the increase in the anaesthesiological and surgical times attributed to the operations required for anchoring it to the tissue, its risk of bending or stinging near the pacemaker or getting tangled with surrounding organs.
The pulse generator located inside a subcutaneous pocket, on its part, can influence or prevent the normal movement of the patient, be rejected, suffer traumas with lesions of the overlying skin and therefore have to be removed early, be unsightly since it is visible at the advanced weight loss stage or make the abdominal housing scar visible, increase the general anaesthetic time and that of the implantation surgery and increase surgical times. Once the battery is drained, it must also be replaced, hence requiring another surgical operation.